A Phase 2, Single-arm Study of the Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease Who Are Carriers of the ε4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alzheon Inc.
- Enrollment
- 84
- Locations
- 4
- Primary Endpoint
- Plasma Biomarker of Core AD Pathology
Study Overview
Brief Summary
The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. In addition, the study will evaluate the extended PK profile over 8 hours in 16 subjects after 65 weeks of treatment.
Detailed Description
The LTE year 1 & 2 study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of LTE study are to continue longitudinal assessment of the efficacy and safety/tolerability of ALZ-801 over a total period of 4 years (2-year Core study plus 2 years of LTE).
Core study: ALZ-801 265 mg twice daily (BID) in the Core Study, Weeks 0-104
LTE year 1: ALZ-801 265 mg BID in the Core Study and the Long-Term Extension (LTE, Weeks 104-208)
LTE year 2: ALZ-801 265mg BID in the Core Study and LTE Year 1 (Weeks 104-156), and LTE Year 2 (Weeks 156-208)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Active treatment
ALZ-801 265 mg tablets once daily for two weeks and twice daily thereafter
Intervention: ALZ-801 (Drug)
Outcomes
Primary Outcomes
Plasma Biomarker of Core AD Pathology
Time Frame: Week 104
Percent change from baseline in p-tau181
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE)
Time Frame: Week 108
Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.
Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume
Time Frame: Weeks 104
Change from baseline in hippocampal volume measured in mm3
Secondary Outcomes
- Plasma Biomarkers of AD and Neurodegeneration(Weeks 104)
- vMRI Biomarker - Ventricular volume and Cortical Thickness(Weeks 104, 156 and 208)
- Additional CSF Biomarkers of AD Pathology and Neurodegeneration(Weeks 104)
- Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE)(Week 160 and week 212)
- Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume(Week 156 and week 208)